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Merck's Keytruda gets FDA breakthrough therapy designation for cHLMerck, commonly known as MSD, has obtained breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Keytruda (pembrolizumab) to treat patients with relapsed or refractor2016/4/27
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NICE recommends PTC's Translarna to treat Duchenne muscular dystrophyThe UK's National Institute for Health and Care Excellence (NICE) has recommended PTC Therapeutics' Translarna (ataluren) for the treatment of Duchenne muscular dystrophy (DMD) caused by a nonsense mu2016/4/26
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EC grants approval for Bristol-Myers' Opdivo to treat renal cell carcinomaBristol-Myers Squibb has obtained approval from the European Commission (EC) for its Opdivo (nivolumab) for previously treated advanced renal cell carcinoma (RCC). RCC is the most common type of kidn2016/4/26
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Catalent plant gets 14 observations from FDAMiami-based Opko was caught off guard last month when the FDA cited concerns over a Catalent ($CTLT) plant in Florida that is producing its drug candidate as the reason the agency was putting off its2016/4/25
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China FDA slams 3 drugmakers on manufacturing lapsesChina FDA has ordered 3 drugmakers to recall certain products off the shelf in the latest effort to enforce good manufacturing practices (GMP) on the firms suspected of sending medicines to the market2016/4/25
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Merck's Keytruda gets FDA breakthrough therapy designation for cHLMerck, commonly known as MSD, has obtained breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Keytruda (pembrolizumab) to treat patients with relapsed or refractor2016/4/22
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US firm Protein Sciences and partners to develop new Zika virus vaccineUS-based vaccine development firm Protein Sciences has reached an agreement with Sinergium Biotech and Mundo Sano to co-develop a new vaccine against the Zika virus. Through using Protein Sciences' p2016/4/22
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ROQUETTE goes EXCiPACT™ to serve its pharmaceuticals customersROQUETTE granted EXCiPACT™, certifying its Good Manufacturing Practices implementation E.U. and U.S. pharmaceutical regulations require drug manufacturers to audit all their starting mat2016/4/21
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FDA speeds ahead with new generic approvals in 2015: ReportThe FDA is finally seeing the fruits of its labor under a program meant to speed up approvals for generic drugs. The agency approved more generics in 2015 than any year prior and made strides toward a2016/4/21
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WHO advisory group recommends use of Sanofi's dengue vaccine DengvaxiaThe World Health Organisation's (WHO) Strategic Advisory Group of Experts (SAGE) on immunisation has recommended the use of Sanofi's dengue vaccine, Dengvaxia. Dengvaxia is the first vaccine in the w2016/4/20